Actively Recruiting
DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study, a Randomized, Placebo-controlled, Cross-over Study With Ertugliflozin in People With Type 2 Diabetes
Led by Amsterdam UMC, location VUmc · Updated on 2025-05-21
34
Participants Needed
2
Research Sites
122 weeks
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
C
Children's Hospital Colorado
Collaborating Sponsor
AI-Summary
What this Trial Is About
SGLT2 inhibitors have demonstrated to mitigate cardiorenal risk in people with type 2 diabetes and are likely to play an increasingly large role in the treatment of patients with diabetes, chronic kidney disease and hypertension. Yet the underlying mechanisms of its protective effects are incompletely understood and the salutary effect may be altered by dietary factors such as sodium intake. Therefore, carefully designed mechanistic trials are needed to better understand the interplay between ertugliflozin and salt intake and to potentially modify salt intake to maximize treatment response. In addition, the study could contribute to hypotheses concerning the effects of SGLT2 inhibitors in combination with other drugs that affect sodium homeostasis and could help to explain the differences in kidney outcomes observed in (outcome) trials, which include different ethnicities with potential differences in dietary habits.
CONDITIONS
Official Title
DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study, a Randomized, Placebo-controlled, Cross-over Study With Ertugliflozin in People With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults diagnosed with type 2 diabetes according to ADA criteria
- HbA1c between 6.5% and 10%
- Age between 18 and 85 years
- Overweight or obese with BMI greater than 25 kg/m2
- Participants of all races/ethnicities are encouraged
- Both sexes; females must be post-menopausal (no menstruation for over 1 year or FSH >31 U/L if uncertain)
- Ability to provide signed written informed consent
- Estimated glomerular filtration rate (eGFR) between 60 and 90 ml/min/1.73m2
- Baseline sodium intake less than 200 mmol/day
- Urine albumin-to-creatinine ratio (UACR) less than 30 mg/mmol
- Stable dose of diabetes medication including Metformin, SU, DPP4-inhibitors, or insulin
- Participants with hypertension must be on a stable dose of RAS inhibitors or other antihypertensive treatment if RAS inhibitors are not tolerated
You will not qualify if you...
- History of unstable or rapidly progressing kidney disease
- eGFR less than 60 or greater than 90 ml/min/1.73m2
- Urine albumin-to-creatinine ratio over 30 mg/mmol
- Current or chronic use of SGLT2 inhibitors, TZD, GLP-1RA, glucocorticoids, immune suppressants, antimicrobial agents, or chemotherapeutics
- Use of antipsychotics, TCAs, and MAOIs must be stable; diuretics only allowed if they can be stopped during the study
- Chronic use of NSAIDs not allowed unless occasional use (1-2 tablets) for non-chronic issues; no NSAIDs within 2 weeks before kidney testing
- History of diabetic ketoacidosis requiring medical intervention within 1 month before screening
- Current urinary tract infection or active nephritis
- Recent (within 6 months) cardiovascular events such as acute coronary syndrome, heart failure NYHA grade II-IV, stroke, or transient ischemic attack
- Severe liver impairment or abnormal liver function (AST or ALT greater than 3 times upper limit normal)
- Active cancer or ongoing treatment other than hormonal therapy
- Severe mental illness
- Substance abuse including alcohol consumption over 4 units/day
- Allergy to study medications
- Investigator site personnel or immediate family members affiliated with the study
- Inability to understand the study or provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Childrens hospital colorado
Denver, Colorado, United States, 80045
Actively Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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